Ceftriaxone tzf

Package leaflet: Information for the patient

Ceftriaxone TZF, 1 g, powder for solution for injection / infusion
Ceftriaxonum
Please read this leaflet carefully before using the medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific person only. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents

1. What is Ceftriaxone TZF and what is it used for
2. Important information before using Ceftriaxone TZF
3. How to use Ceftriaxone TZF
4. Possible side effects
5. How to store Ceftriaxone TZF
6. Contents of the pack and other information

1. What is Ceftriaxone TZF and what is it used for

Ceftriaxone TZF is an antibiotic used in adults and children (including newborns). It works by killing susceptible bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxone TZF is used to treat infections:

• of the brain (meningitis),
• of the lungs,
• of the middle ear,
• of the abdomen and abdominal cavity wall (peritonitis),
• of the urinary tract and kidneys,
• of bones and joints,
• of the skin and soft tissues,
• of the blood,
• of the heart.

This medicine may also be used:

• to treat certain sexually transmitted infections (gonorrhoea and syphilis),
• to treat patients with low white blood cell count (neutropenia) who have fever due to bacterial infection,
• to treat chest infections in adults with chronic bronchitis,
• to treat Lyme disease (a tick-borne disease) in adults and children, including newborns from the 15th day of life,
• to prevent infections during surgery.

2. Important information before using Ceftriaxone TZF

When not to use Ceftriaxone TZF:

• if the patient is allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems, monobactams); symptoms of such a reaction include: sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of the hands, feet and ankles (ankle joints), chest pain, and rapidly developing severe rash;
• if the patient is allergic to lidocaine and is to receive Ceftriaxone TZF by intramuscular injection.

Ceftriaxone TZF must not be used in young children if:

• the child is a premature infant,
• the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice [yellowing of the skin and/or the whites of the eyes], or is to receive intravenous medication containing calcium.

Warnings and precautions
Before starting treatment with Ceftriaxone TZF, discuss with your doctor, pharmacist or
nurse if:

• the patient has recently received or is about to receive products containing calcium,
• the patient has recently had diarrhoea after antibiotic treatment. The patient has ever had intestinal problems, particularly colitis (inflammation of the large intestine),
• the patient has problems with the liver or kidneys,
• the patient has gallstones or kidney stones,
• the patient has other diseases such as haemolytic anaemia (reduced number of red blood cells causing paleness, weakness or shortness of breath),
• the patient is on a low-sodium diet,
• the patient currently has or has previously had any of the following symptoms: rash, redness of the skin, blisters around the lips, eyes or mouth, peeling of the skin, high fever, flu-like symptoms, increased liver enzyme activity observed in blood tests, increased number of a certain type of white blood cells (eosinophilia), and swollen lymph nodes (symptoms of severe skin reactions, see also section 4 “Possible side effects”),
• the patient has liver or kidney problems (see section 4).

Blood or urine tests
If the patient is receiving Ceftriaxone TZF for a prolonged period, regular blood tests may be necessary. Ceftriaxone TZF may affect the results of urine glucose testing and of a blood test known as the Coombs test. If the patient is undergoing tests, inform the person collecting the sample that the patient is receiving Ceftriaxone TZF.
If the patient has diabetes or needs to monitor blood glucose levels, do not use test methods that may incorrectly measure blood glucose levels during ceftriaxone treatment. If the patient monitors blood glucose levels, check the instructions and inform the doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

Children
Before giving Ceftriaxone TZF to a child, discuss with the doctor, pharmacist or nurse if the child has recently received or is about to receive intravenous calcium-containing products.

Ceftriaxone TZF and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• an antibiotic belonging to the aminoglycoside group,
• an antibiotic called chloramphenicol (used to treat infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Pregnancy
The doctor will assess the benefits of treatment with Ceftriaxone TZF for the mother and the potential risks for the unborn child.

Breastfeeding
Ceftriaxone is excreted in human milk in small amounts. During therapeutic doses, no effects of ceftriaxone on the breastfed newborn or infant are expected. However, the risk of diarrhoea and fungal mucosal infections cannot be excluded. The possibility of allergic sensitisation should also be considered.
The doctor will decide whether to discontinue breastfeeding or to discontinue ceftriaxone therapy, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery
Ceftriaxone TZF may cause dizziness. If the patient experiences dizziness, he or she should not drive or use tools or operate machinery. Inform the doctor if such symptoms occur.

Ceftriaxone TZF contains sodium
Each gram of medicine contains approximately 83 mg of sodium (the main component of table salt). This corresponds to 4.2% of the maximum recommended daily sodium intake in the diet of adults.

3. How to use Ceftriaxone TZF

Ceftriaxone TZF is usually administered by a doctor or nurse. It may be given

• as an intravenous infusion (drip) or by direct injection into a vein, or
• into a muscle. Ceftriaxone TZF is prepared by a doctor, pharmacist, or nurse and must not be mixed or administered simultaneously with calcium-containing solutions.

Usual dosage
The appropriate dose of Ceftriaxone TZF will be determined by the doctor. The dose depends on
the severity and type of infection; whether the patient is taking other antibiotics; the patient's age and body weight;
and the function of the patient's liver and kidneys. The number of days or weeks during which the patient will
receive Ceftriaxone TZF depends on the type of infection.
Adults, elderly patients, and children aged 12 years and older with body weight of at least 50 kg

• 1 to 2 g once daily, depending on the severity and type of infection. In severe infections, the doctor may use a higher dose (up to 4 g once daily). If the daily dose exceeds 2 g, the medicine may be given as a single dose or in two separate doses.

Newborns, infants, and children from day 15 to 12 years of age with body weight below 50 kg

• 50 to 80 mg of Ceftriaxone TZF per kg of body weight once daily, depending on the severity and type of infection. In severe infections, the doctor may use a higher dose of up to 100 mg per kg of body weight, with a maximum of 4 g once daily. If the daily dose is

greater than 2 g, the medicine may be administered as a single daily dose or in two separate doses.

• Children with body weight of 50 kg or more should receive the usual adult dose.

Newborns aged 0–14 days

• 20 to 50 mg of Ceftriaxone TZF per kg of body weight once daily, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of body weight.

Patients with impaired liver or kidney function
The patient may receive a dose different from the usual. The doctor will determine the appropriate
dose of Ceftriaxone TZF and will closely monitor the patient's condition depending on the severity of liver or kidney disease.
Use of more Ceftriaxone TZF than prescribed
If a larger than prescribed dose is accidentally received, contact a doctor or the nearest hospital immediately.
Missed dose of Ceftriaxone TZF
If the patient misses an injection, it should be given as soon as possible. However, if it is almost time for the next injection, the missed dose should not be administered. Do not use a double dose (two injections at the same time) to make up for a missed dose.
Stopping treatment with Ceftriaxone TZF
Do not stop using Ceftriaxone TZF unless instructed by the doctor. If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur during treatment with this medicine.
Severe allergic reactions (frequency unknown, cannot be estimated from available data)
If a severe allergic reaction occurs, you must immediately inform your doctor.
Symptoms to watch for:

• sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult;
• sudden swelling of the hands, feet and ankles (ankle joints).

Severe skin reactions (frequency unknown, cannot be estimated from available data)
If a severe skin reaction occurs, you must immediately inform your doctor.
Symptoms to watch for:

• rapidly developing severe rash, with blisters or peeling of the skin and possible blisters in the mouth [Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome)];
• any of the following symptoms: spreading rash [e.g. acute generalized exanthematous pustulosis (AGEP)], high body temperature, increased liver enzyme activity, abnormal blood test results (eosinophilia), swollen lymph nodes and involvement of other organs [drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome];
• Jarisch-Herxheimer reaction causing fever, chills, headache, muscle pain and skin rash, usually self-limiting; this reaction occurs shortly after starting treatment with Ceftriaxone TZF for infections caused by spirochetes, such as Lyme disease;
• chest pain associated with an allergic reaction, which may be a sign of allergy-induced heart attack (Kounis syndrome).

Treatment with ceftriaxone – especially in elderly patients with severe renal or neurological disorders – may rarely cause decreased level of consciousness, abnormal movements, agitation and seizures.
Other possible adverse effects
Common (affects up to 1 in 10 patients)

• abnormalities in white blood cells (such as decreased leukocyte count and increased eosinophilia) and platelets (decreased platelet count),
• loose stools or diarrhoea,
• changes in blood test results assessing liver function,
• rash.

Uncommon (affects up to 1 in 100 patients)

• fungal infections (e.g. candidiasis),
• decreased white blood cell count (granulocytopenia),
• decreased red blood cell count (anaemia),
• problems with blood clotting; symptoms may include easy bruising, as well as joint pain and swelling,
• headache,
• dizziness,
• nausea and/or vomiting,
• itching (pruritus),
• pain or burning along the vein into which Ceftriaxone TZF was administered; pain at the injection site,
• high body temperature (fever),
• abnormal kidney function test results (increased blood creatinine concentration).

Rare (affects up to 1 in 1000 patients)

• inflammation of the large intestine (colitis); symptoms include diarrhoea, usually with blood and mucus, abdominal pain and fever,
• breathing difficulties (bronchospasm),
• raised rash (urticaria), which may affect large areas of the body, itching and swelling,
• blood or sugar in the urine,
• oedema (fluid retention),
• chills.

Frequency not known (cannot be estimated from available data)

• secondary infection that cannot be treated with previously prescribed antibiotics,
• a type of anaemia in which red blood cells are destroyed (haemolytic anaemia),
• marked decrease in white blood cell count (agranulocytosis),
• seizures,
• severe dizziness (sensation of spinning),
• pancreatitis; symptoms include severe abdominal pain radiating to the back,
• inflammation of the mucous membrane lining the mouth,
• inflammation of the tongue; symptoms include swelling, redness and pain of the tongue,
• disorders related to the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, very dark urine and pale stools,
• neurological condition that may occur in newborns with severe jaundice (kernicterus),
• kidney problems caused by deposition of calcium-ceftriaxone salts. These may manifest as pain during urination or production of small amounts of urine,
• false positive Coombs test result (a test detecting certain blood disorders),
• false positive galactosemia test result (abnormal accumulation in the body of a sugar called galactose),
• Ceftriaxone TZF may affect the results of certain blood glucose tests
  • this should be discussed with your treating physician.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Ceftriaxone TZF

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep the vial in the original packaging to protect it from light.
Any unused solution for injection or infusion must be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the package and other information

What Ceftriaxone TZF contains
The active substance is ceftriaxone.
Each vial contains 1 g of ceftriaxone (as sodium ceftriaxone).
The medicine contains no other ingredients.

What Ceftriaxone TZF looks like and contents of the pack
A nearly white or yellowish crystalline powder, slightly hygroscopic.
Pack: one vial in a cardboard box.

Marketing Authorisation Holder and Importer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw
Telephone number: 22-811-18-14

For further information about this medicine, please contact the Marketing Authorisation Holder.

Information intended exclusively for medical professionals

Please read the Summary of Product Characteristics
Ceftriaxone TZF, 1 g, powder for solution for injection / infusion

• Stability of prepared solutions

The prepared ceftriaxone injection solution maintains physicochemical stability at 25°C for 24 to 30 hours, and at 5°C for 72 to 240 hours, depending on the solvent used and its volume (Table 1). The diluted ceftriaxone solution maintains physicochemical stability at 25°C for 6 to 48 hours, and at 5°C for 24 to 240 hours, depending on the solvent used and its volume (Table 1).
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration, which must not exceed 24 hours at a temperature of 2°C to 5°C (refrigerator).
Table 1. Stability of ceftriaxone solutions depending on the solvent used and its volume.

Before administering the medication, check the appearance of the solution. The solution should be yellowish or brownish-yellow. The solution may only be administered if it is clear and practically free from particles visible to the naked eye.
Any unused portions of the product or waste materials must be disposed of in accordance with local regulations.
To prepare the solution for administration by a specified route, only use the solvents listed in the table above – see Table 1.

Method of administration
Intramuscular injection
The solution should be administered deep into the gluteal muscle.
Before administering the medication in a 1% lidocaine solution, ensure that the patient is not allergic to lidocaine.
The medicinal solution containing lidocaine must not be administered intravenously.
Do not administer more than 1 g at a single injection site.
Doses greater than 2 g should be administered intravenously.

Intravenous injection
The prepared solution should be administered slowly intravenously over approximately 5 minutes.

Intravenous infusion
The infusion should be administered over at least 30 minutes.

Do not use calcium-containing diluents, such as Ringer's solution or Hartmann's solution, for reconstitution of Ceftriaxone TZF or for further dilution of the prepared intravenous solution, due to the risk of precipitate formation. Calcium salt of ceftriaxone may also precipitate when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration set. Do not administer ceftriaxone simultaneously through a Y-site with calcium-containing intravenous solutions, including calcium-containing intravenous infusion solutions, e.g., for parenteral nutrition. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered consecutively, provided that the infusion lines are thoroughly flushed between infusions with a compatible, pharmaceutically appropriate solution.

• Pharmaceutical incompatibilities

According to literature reports, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, and aminoglycoside antibiotics.
Solutions containing ceftriaxone must not be mixed with or have other substances added to them, except those mentioned above. In particular, due to the risk of precipitate formation, diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) must not be used to dissolve ceftriaxone in the vial or for further dilution of the prepared intravenous solution. Ceftriaxone must not be mixed or co-administered simultaneously with calcium-containing solutions, including those used in total parenteral nutrition.